Additional Follow-up from the ABCD Trial in Patients with Type 2 Diabetes and Hypertension

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Abstract
In 1998 we presented data from the Appropriate Blood Pressure Control in Diabetes (ABCD) trial on the effect of nisoldipine as compared with enalapril on cardiovascular outcomes after five years of follow-up in 470 patients with hypertension and type 2 diabetes.1 The nisoldipine therapy was terminated in the cohort with hypertension on July 14, 1997, as recommended by the study's data and safety monitoring committee. At that time, there had been 25 myocardial infarctions in the nisoldipine group, as compared with 5 myocardial infarctions in the enalapril group, resulting in an unadjusted risk ratio of 5.5 (95 percent confidence interval, 2.1 to 14.6) and an adjusted risk ratio of 7.0 (95 percent confidence interval, 2.3 to 21.4). During the remaining year of the study, a private detective identified six additional documented nonfatal myocardial infarctions, which were confirmed by the blinded end-point committee. Thus, since the publication of the article, the number of patients in the nisoldipine group with fatal or nonfatal myocardial infarctions has increased from 25 to 27, and the number in the enalapril group has increased from 5 to 9. Hence, the unadjusted risk ratio is now 3.3 (95 percent confidence interval, 1.5 to 7.1; P=0.029) rather than 5.5, and the adjusted risk ratio is now 4.2 (95 percent confidence interval, 1.8 to 10.1; P=0.001) rather than 7.0.